CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Dalteparin sodium injectiondrug
Likely dose
Dalteparin sodium 200 units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six daysAI-extracted
Key inclusion· 1
  • ✓Confirmed superficial thrombophlebitis of upper or lower extremity by ultrasound imaging
Key exclusion· 7
  • ✕Active, clinically significant bleeding
  • ✕Known hypersensitivity to NSAIDs, heparin, or derivatives
  • ✕Currently pregnant or less than 1 week post-partum
  • ✕Acquired or inherited bleeding disorder/diathesis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00264381
NCT00264381Phase 4Completed
CompareCT.gov

Management of Superficial Thrombophlebitis

University of Oklahoma·interventional·Posted Dec 12, 2005·Updated Nov 18, 2013

In Brief

A Phase 4 clinical trial evaluating Dalteparin sodium injection for Superficial Thrombophlebitis and 2 related conditions. Completed, enrolled 72 participants across 2 sites.

Detailed Summary

The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2005
Enrollment StartOct 1, 2002
Primary CompletionSep 1, 2009
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.6 years ago

Interventions

Dalteparin sodium injectiondrug

Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.